FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLEURAL DRAINAGE SYSTEM #PDS-4300
K Number: K812224
·
Decision Sep 9, 1981
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
47
Applicant Total
55
Review Days
30
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Basic Information
- Device Name
- PLEURAL DRAINAGE SYSTEM #PDS-4300
- K Number
- K812224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Bentley Laboratories, Inc.
- Date Received
- August 10, 1981
- Decision Date
- September 9, 1981
- Product Code
- KDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KDQ | Bottle, Collection, Vacuum | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K874841 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | Feb 2, 1988 | Substantially Equivalent |
| K874867 | CATR(TM)-H CARDIOTOMY HOLDER | Feb 2, 1988 | Substantially Equivalent |
| K874618 | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER | Jan 19, 1988 | Substantially Equivalent |
| K823273 | BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. | Jan 5, 1983 | Substantially Equivalent |
| K823359 | OXYGEN CONSUMPTION MONITOR #OCM-0100 | Jan 5, 1983 | Substantially Equivalent |